The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP induction chemotherapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
Voluntary participation and signed informed consent.
Age 18-65 years, male or non-pregnant female.
Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
Previously untreated patients with no history of other malignancies; initial treatment for nasopharyngeal carcinoma.
Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
Pathologically confirmed keratinizing squamous cell carcinoma (WHO type I).
Receipt of systemic or topical glucocorticoid therapy within 4 weeks prior to enrollment.
Participation in another clinical trial of an investigational drug within 3 months prior to treatment.
Sun Yat-sen University
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator